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|Year : 2016 | Volume
| Issue : 1 | Page : 1--2
Consumer reporting of medicine side effects: A dream fulfilled?
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal
|How to cite this article:|
Hazra A. Consumer reporting of medicine side effects: A dream fulfilled?.Indian J Pharmacol 2016;48:1-2
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Hazra A. Consumer reporting of medicine side effects: A dream fulfilled?. Indian J Pharmacol [serial online] 2016 [cited 2022 Sep 26 ];48:1-2
Available from: https://www.ijp-online.com/text.asp?2016/48/1/1/174357
The Pharmacovigilance Programme of India (PvPI) is now in full swing. Building on both the successes and the failures of its predecessor - the National Pharmacovigilance Programme - the current program, being coordinated by the Indian Pharmacopeia Commission at Ghaziabad, has built up a network of some 90 adverse drug reaction (ADR) Monitoring Centres (AMCs) across the country. Another 50 centers have newly started or are starting operations. The program is providing financial, logistic, and technical support to the AMCs. Designated Regional Resource Centres for Training and Technical Support are taking up training and communication activities. In 5 years since program inception, our contribution to the World Health Organization International Drug Monitoring Database (VigiBase), being maintained by the Uppsala Monitoring Centre, has gone from 0% to 2%. By virtue of the sheer size of its population, India has the potential to build up one of the largest spontaneous ADR reporting systems in the world. We can dream big in this regard.
PvPI has moved recently to make the program all-inclusive by throwing open reporting doors to all people who consume medicines and not just health professionals. A toll-free consumer helpline (1800 180 3024 operational on weekdays during office hours) and a dedicated e-mail address ([email protected]) have been launched - to encourage consumers wishing to report drug-related problems and direct them to nearby AMCs. Consumers reporting of medicines side effect forms have been uploaded to the IPC website (http://www.ipc.gov.in) in Hindi and vernacular languages (such as Bengali, Gujarati, Kannada, Malayalam, Marathi, Oriya, and Tamil). More languages will surely be added in future. Advertisements are being brought out in mass media to raise awareness about this issue.
While this is a welcome move to improve the reach of the program, some questions arise and need to be addressed now:
Is the Indian consumer mature enough to report medicine adverse events on their own?Should they be trained on how to report such events?Should consumers report directly or through their healthcare providers?
The first question is pertinent because the PvPI is a system of spontaneous reporting of suspected drug-related problems which eventually may or may not turn out to be causally related to the suspect drug. Causality inference is a tricky issue even for the most seasoned clinicians and pharmacovigilance professionals. Assuming the Indian consumer to be mature enough to report on his own places a lot of responsibility on his shoulders. On one hand, there is the advantage that reporting by responsible consumers will increase the quantum of reports and bring problems related to nonprescription products, which nevertheless may have medicinal properties, within the ambit of the program. On the other hand, there is the apprehension that trivial or repetitive reports by fastidious consumers can overburden the system without really contributing to new or meaningful knowledge. For instance, suppose I am a consumer who is taking drug X and experience a bad taste in the mouth, fatigue at the end of the day, some cough and cold symptoms, hard stools 1 day, and loose motion the next day, do not feel like eating for 2 days and feel that my memory is not what it used to be. I start reporting all as drug X-related events, which in all probability is unlikely to be so. Again, a consumer may be on multiple drugs for multiple illnesses and even if he is having genuine drug-related problems, may feel too overwhelmed by the many possibilities to report any at all.
These complexities then lead to the second question on whether consumers need some training to report medicine side effects. The answer, if in the affirmative, begets the question, how? The instructions provided on the reporting form itself are not sufficient. Regional training centers and AMCs can do their bit but their efforts in isolation would be tantamount to proverbial drops in the ocean. Perhaps, the only feasible option is sustained awareness campaigns through mass media. Funds will have to be procured for such sustained campaigning, and the interest of the mass media itself requires kindling.
Coming to the third question of whether consumers should approach their healthcare providers before reporting, it is obvious that a scrutiny by the health professional can improve the quality and therefore the "completeness score" of the report. It can also remove the hassle for the individual consumer to fill up a form and then spend some more time on submitting it to the proper forum and satisfying the subsequent queries that may be raised. He or she can simply leave the form with the healthcare provider who would know how to deal with these reports. This will not be necessary if the consumer could report details directly online but that may compromise quality. Then, again conflicts of interest may arise. If a consumer reports through the healthcare provider, does it remain consumer reporting anymore? Would the healthcare provider deal with a report impartially if it happened to relate to his or her own prescribing or dispensing activity? Would the provider be interested at all if the reports pertained to self-medication? Remember, we are not talking of an occasional report but sustained activity.
Only the future will tell whether the PvPI dream of making it a nationwide popular program will come true. In the meantime, the issue does open up interesting research possibilities for pharmacologists and other healthcare professionals. For instance, one can identify a cohort of interested consumers, make them aware, demonstrate to them how to report and encourage them periodically, and then compare the reporting trends over a period of time in comparison to a control cohort who are simply made aware. It is of course much easier to propose than to actually do such a cohort study, but then research always involves perspiration. This journal would be happy to communicate the results of such inspired research to the world and thereby do its bit to keep the PvPI dream alive.